5 Safety

5 Safety

This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.

5.1 Severe pain immediately after the procedure was reported in 6% (2/32) of patients in a case series of 32 patients with massive irreparable rotator cuff tear. The pain improved 6 weeks after the procedure. Anterior shoulder pain was reported in 6% (2/32) of patients in the same case series of 32 patients. The cause of the pain may have been device displacement (reported in section 5.4).

5.2 Suspected synovitis without cyst formation was reported in 2 patients 3 years after implantation (seen on MRI) in a prospective case series of 20 patients with massive irreparable rotator cuff tear (no further details given). Local inflammation or suspected aseptic synovitis was reported in 6% (3/50) of patients in a prospective case series of 50 patients with massive rotator cuff tear (no further details reported).

5.3 Deterioration in shoulder function was reported in 1 patient in the prospective case series of 50 patients with massive rotator cuff tear; the device was removed (no further details reported).

5.4 Displacement of the device was reported in 1 patient in the prospective case series of 50 patients (no further details reported). Suspected displacement of the device was reported in 6% (2/32) of patients in the case series of 32 patients.

5.5 A technical issue with the device during the procedure was reported in 1 patient in the case series of 32 patients. The device had to be changed for another device.

5.6 In addition to safety outcomes reported in the literature, specialist advisers are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so). For this procedure, specialist advisers reported bursting of the balloon as an anecdotal adverse event. They considered that the following were theoretical adverse events: nerve injury, balloon rejection and inflammatory response, infection, increased pain, and secondary bony changes (erosion).

  • National Institute for Health and Care Excellence (NICE)